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Generated: November 18, 2018

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Details for New Drug Application (NDA): 020392

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NDA 020392 describes CYSTAGON, which is a drug marketed by Mylan and is included in one NDA. It is available from one supplier. Additional details are available on the CYSTAGON profile page.

The generic ingredient in CYSTAGON is cysteamine bitartrate. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cysteamine bitartrate profile page.
Summary for 020392
Tradename:CYSTAGON
Applicant:Mylan
Ingredient:cysteamine bitartrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020392
Mechanism of ActionCystine Disulfide Reduction
Suppliers and Packaging for NDA: 020392
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYSTAGON cysteamine bitartrate CAPSULE;ORAL 020392 NDA Mylan Pharmaceuticals Inc. 0378-9040 0378-9040-05 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-9040-05)
CYSTAGON cysteamine bitartrate CAPSULE;ORAL 020392 NDA Mylan Pharmaceuticals Inc. 0378-9045 0378-9045-05 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-9045-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:Aug 15, 1994TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:Aug 15, 1994TE:RLD:Yes

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